In this article, Catalyst comments on FDA’s developing plans related to collection and analysis of demographic subgroup data in clinical trials. Under FDASIA, the agency is required to develop an action plan on demographic subgroup participation in trials by August 2014.

Catalyst’s Nancy Bradish Myers, a former special assistant/senior strategic advisor to the FDA’s acting deputy commissioner for operations, notes that “while guidance is usually helpful, developing and publishing it is a slow process.”

She goes on to discuss personalized medicine, noting that tailoring treatments based on genomics is “moving at light speed” and by its “nature defining the most appropriate subpopulations.” Therefore, “any guidance contemplated should be crafted to ensure that it focuses on what is truly helpful to the relevant subpopulations and does not add unnecessary costs or delay the drug development process.”

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This is fantastic news Proteus Team! Congrats to you and TennCare. As the importance of remote monitoring is realized- especially during and immediately following this COVID pandemic, TennCare will be seen as an early adopter. This will be an important…https://lnkd.in/erD_A2G

FDA continues working around the clock to combat the #COVID19 pandemic. Here is our latest update: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-14-2020

In @AISHealth, Catalyst’s Jeff Myers weighs in on the #SCOTUS 8-1 ruling of #CMS owing billions to health insurers in risk corridor funding, discussing while it’s mandated by law, the risk corridor program isn’t well designed to begin with. http://catalysthcc.com/2020/05/04/health-insurers-hail-scotus-ruling-in-risk-corridors-case/

In @thehill, Catalyst’s Jeff Myers argues it’s unlikely early #COVID19 treatments will have remarkably high efficacy, but it’s still worth making and having them be available options to combat the deadly #coronavirus. https://thehill.com/policy/healthcare/494936-race-for-coronavirus-vaccine-faces-early-challenges